LES 02 EA - Initial Certification for Chemical Laboratory

Permit Fact Sheet

What is the purpose of this permit?

Certification and operation of environmental analysis laboratories is authorized pursuant to MGL c. 21, s.27, c. 21A, s. 2(28), c. 21C, s. 4, c. 21E, s. 3, c. 111 § 142A-142E, 150A, 160 and 310 CMR 42.00. These regulations establish a program for Department certification of laboratories to conduct analytical measurements for purposes of determining compliance with Department standards where the Department or a client requires such measurements be conducted by a certified laboratory. A program for the certification of laboratories conducting analytical measurements of drinking water is necessary for Massachusetts to meet the requirements of primary enforcement responsibility under the Safe Drinking Water Act and the National Primary Drinking Water Regulations. Massachusetts also certifies laboratories analyzing non-potable water. The laboratory certification program identifies laboratories capable of consistently producing valid data (although certification does not guarantee the validity of the data).

Who must apply?

Any person (private corporation, individual, partnership or association, or other entity) who intends to conduct analytical measurements for the purposes of determining compliance with Department standards where the Department or the laboratory’s client requires such measurements be conducted by a certified laboratory.

What other requirements should be considered when applying for this permit?

a. What prerequisites should be considered before applying for this permit?

None.

b. What additional technical information must be provided to apply for this permit?

• Results of Proficiency Tests (PTs) performed by the laboratory must be submitted by the laboratory’s PT Provider in accordance with the current Wall Experiment Station PT Policy.

• Laboratory Quality Assurance Plan.

• A laboratory located out-of-state seeking certification under 310 CMR 42.16 must submit a copy of the certificate and certified parameter list issued by its resident state or the USEPA and a copy of the on-site inspection report written by the certifying authority of the laboratory's resident state or the USEPA.

The Transmittal form is a unique numbered form which must be submitted with each application package. Transmittal Form must be submitted as follows:

• One copy accompanies the permit application sent to the MassDEP Primary Permitting Location indicated below.

• One copy accompanies payment which is sent to the MassDEP post office box as explained in Question 6 below.

• One copy for applicant's records.

All additional information, as defined in Question 3b above and identified in the Application Completeness checklist, included in this application package, must be submitted with a copy of the transmittal form for the application to be processed properly.

Pursuant to 310 CMR 4.02 the following entities are exempt from these fees: any city, town, county, or district of the Commonwealth or any municipal housing authority. Applications for permits made by another state agency which cost $100 or less are exempt from payment.

When will I get the permit?

If your application is administratively complete when first submitted, and if the information you provide is technically sufficient, MassDEP must provide a decision on the permit by the end of the timelines for the administrative review, the technical review, the inspection review and any public comment review that may be required. MassDEP must refund the fee if it cannot issue its decision within the required time period.

It is in the best interest of the applicant to submit a complete, thorough and accurate application. If the application has administrative deficiencies or technical deficiencies, a second review period will be required for each, thereby extending the timeframe for a final decision on the permit application. Further information on timelines is presented in questions 8, 9 and 10.

When does the timeline begin?

The timeline begins on the day following the receipt of a payment and an application. The schedule for timely action will be suspended if there is a failure of payment for any reason following the recording date. MassDEP will inform you of the timelines and the name and telephone number of the individual who will be handling your application.

What are the timelines for permit review?

Schedules for timely action vary for each permit, but all will include some combination of the following review periods:

Administrative Completeness Review (AC) - to determine whether all required elements of the application have been provided by the applicant. The Department may request additional information during the review. An initial administrative completeness review will result in:

• a determination of administrative completeness, or

• a statement of administrative deficiencies.

If necessary, a second administrative completeness review will be conducted. After the applicant responds to the statement of deficiencies, the second AC review period will be the same number of days allowed in the first AC review period. The result of the second review will be:

• a determination of administrative completeness, or

• a denial of the permit application.

Technical Review (T1) - to review the merits of the permit application and supporting materials. More information may be requested without stopping the clock during a technical review. The result of an initial technical review is:

• a decision to grant or deny the permit, or

• a statement identifying technical or other substantive deficiencies in the application process, or

• a decision to conduct an on-site inspection of the laboratory.

An applicant may decline to provide additional information in response to a statement of technical deficiency and obtain a decision by MassDEP based on the record at the time. If this option is chosen, there will be no supplemental technical review.

Note: A failure to respond to a statement of technical deficiency within the time allowed by the Department will result in a permit denial with no refund.

Supplemental Technical Review (T2) - to review the merits of the permit application and supporting materials as supplemented, modified, or amended as a result of a deficiency in T1. A supplemental technical review may be required if MassDEP would otherwise deny or substantially modify or restrict the certificate based on the available information. Additional information may be requested during the review, but the clock will not stop. A supplemental technical review will result in:

• a decision to grant or deny the permit, or

• an on-site inspection.

On-Site Inspection and Post Inspection Review - to conduct an on-site inspection of the facilities to determine whether the laboratory satisfies the Department's standards for certification. An on-site laboratory inspection and post inspection review will result in:

• a statement identifying deficiencies, if any, identified during the on-site or post inspection review, and

• a decision to grant or deny the permit.

Supplemental Inspection Review - to review the merits of the on-site inspection and supporting materials as supplemented, modified, or amended. Additional information may be requested during the review, but the clock will not stop. A supplemental inspection review will result in:

What if MassDEP does not complete its work before the timeline expires?

Generally, if the permit is not ruled on by the final deadline, MassDEP will refund the fee and continue the process. Approval does not depend on adherence to the timelines by MassDEP, nor is a permit considered to be granted if the timelines are not met. This refund system is intended to demonstrate the good faith efforts of MassDEP to increase efficiency while continuing to protect the environment. Please be advised the timelines may be affected by provisions in the regulations including but not limited to failure of payment, other agency actions and judicial and enforcement proceedings. Please refer to the regulations for more detail.

What if my application is withdrawn?

If an applicant withdraws an application before the beginning of the technical review, 50% of the fee will be refunded. If the applicant withdraws at any time after the technical review begins, none of the fee will be refunded.

What is the purpose of the annual compliance assurance fee for this permit?

Compliance assurance fees are designed to provide adequate resources for enforcement, inspection and monitoring programs. These resources are essential to the improvement and effective maintenance of these programs. Without assured compliance, some members of the regulated community will continue to violate environmental laws and regulations, while honest members will be placed at a competitive disadvantage. Generally, no annual compliance assurance fee shall be assessed for a permit in the same fiscal year in which the permit is issued. Please consult 310 CMR 4.03 of the fees regulations for further information.

• Make sure the proper, approved methods are listed and performed by the laboratory for the matrix in which certification is requested, e.g., drinking water methods for certification in the potable water category.

• Keep all application materials up to date by notifying the MassDEP of any changes in the application including any changes in personnel. Submit new Proficiency Test Study results as they become available. Laboratories located outside Massachusetts should provide copies of updated certificates and certified parameter lists as issued by the laboratory’s resident state or the USEPA.

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